NCT02753439

Brief Summary

A prospective study examining bilateral 3rd molar extraction, by a split mouth protocol the investigators augment unilaterally and compare periodontal parameters in between.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

April 27, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

March 20, 2016

Last Update Submit

April 25, 2016

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (2)

  • Mobility (Scale 0,1,2,3), change is being assessed.

    Mobility will be assessed in the intervals mentioned above, and compared over time.

    Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp

  • Pocket Depth (mm), change is being assessed.

    Pocket depth will be assessed in the intervals mentioned above, and compared over time.

    Pre opp (base line), 1 month post opp, 3 months post opp, 6 months post opp

Study Arms (1)

3rd molar

EXPERIMENTAL

Drug: Geistlich Bio Oss

Drug: Geistlich Bio Oss

Interventions

Geistlich Bio OssDRUG

Extraction of Impacted 3rd Molars,

Also known as: Bone Support
3rd molar

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Bilateral impacted 3rd molars.
  • Healthy individuals

You may not qualify if:

  • Smokers
  • Alcohol abusers
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2016

First Posted

April 27, 2016

Study Start

February 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2019

Last Updated

April 27, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share